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FLOLAN (epoprostenol sodium) must be reconstituted only as directed using STERILE DILUENT for FLOLAN (epoprostenol sodium) . FLOLAN (epoprostenol sodium) must not be reconstituted or mixed with any other parenteral medications or solutions prior to or during administration.
Abrupt withdrawal (including interruptions in drug delivery) or sudden large reductions in dosage of FLOLAN (epoprostenol sodium) may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia. In clinical trials, one Class III patient's death was judged attributable to the interruption of FLOLAN (epoprostenol sodium) . Avoid abrupt withdrawal.
See ADVERSE REACTIONS: Adverse Events Attributable to the Drug Delivery System.
FLOLAN (epoprostenol sodium) should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension. Carefully establish the diagnosis of idiopathic or heritable PAH or PAH/CTD.
FLOLAN (epoprostenol sodium) is a potent pulmonary and systemic vasodilator. Initiate FLOLAN (epoprostenol sodium) in a setting with adequate personnel and equipment for physiologic monitoring and emergency care. Dose initiation has been performed during right heart catheterization and without cardiac catheterization. During dose initiation, asymptomatic increases in pulmonary artery pressure coincident with increases in cardiac output occurred rarely. In such cases, consider dose reduction, but such an increase does not imply that chronic treatment is contraindicated.
FLOLAN (epoprostenol sodium) is a potent inhibitor of platelet aggregation. Therefore, expect an increased risk for hemorrhagic complications, particularly for patients with other risk factors for bleeding (see PRECAUTIONS: DRUG INTERACTIONS).
During chronic use, deliver FLOLAN (epoprostenol sodium) continuously on an ambulatory basis through a permanent indwelling central venous catheter. Unless contraindicated, administer anticoagulant therapy to patients receiving FLOLAN (epoprostenol sodium) to reduce the risk of pulmonary thromboembolism or systemic embolism through a patent foramen ovale. To reduce the risk of infection, use aseptic technique in the reconstitution and administration of FLOLAN (epoprostenol sodium) and in routine catheter care. Because FLOLAN (epoprostenol sodium) is metabolized rapidly, even brief interruptions in the delivery of FLOLAN (epoprostenol sodium) may result in symptoms associated with rebound pulmonary hypertension including dyspnea, dizziness, and asthenia. Intravenous therapy with FLOLAN (epoprostenol sodium) will likely be needed for prolonged periods, possibly years, so consider the patient's ability to accept and care for a permanent intravenous catheter and infusion pump.
Based on clinical trials, the acute hemodynamic response to FLOLAN (epoprostenol sodium) did not correlate well with improvement in exercise tolerance or survival during chronic use of FLOLAN (epoprostenol sodium) . Adjust dosage of FLOLAN (epoprostenol sodium) during chronic use at the first sign of recurrence or worsening of symptoms attributable to pulmonary hypertension or the occurrence of adverse events associated with FLOLAN (see DOSAGE AND ADMINISTRATION). Following dosage adjustments, monitor standing and supine blood pressure and heart rate closely for several hours.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. A micronucleus test in rats revealed no evidence of mutagenicity. The Ames test and DNA elution tests were also negative, although the instability of epoprostenol makes the significance of these tests uncertain. Fertility was not impaired in rats given FLOLAN (epoprostenol sodium) by subcutaneous injection at doses up to 100 mcg/kg/day (600 mcg/m²/day, 2.5 times the recommended human dose [4.6 ng/kg/min or 245.1 mcg/m²/day, IV] based on body surface area).
Pregnancy Category B
Reproductive studies have been performed in pregnant rats and rabbits at doses up to 100 mcg/kg/day (600 mcg/m²/day in rats, 2.5 times the recommended human dose, and 1,180 mcg/m²/day in rabbits, 4.8 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to FLOLAN (epoprostenol sodium) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
The use of FLOLAN (epoprostenol sodium) during labor, vaginal delivery, or cesarean section has not been adequately studied in humans.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLOLAN (epoprostenol sodium) is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of FLOLAN (epoprostenol sodium) in pulmonary hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Last reviewed on RxList: 5/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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